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Is there a health risk in your soft drink?

Stronger regulations for caramel coloring in food and beverages are needed

Published: January 2014

The term “caramel coloring” may remind you of candy, but it’s far from the same thing. Caramel color is added to many foods and beverages consumers buy every day, primarily to make these products darker in color. And as recent testing by Consumer Reports found, this color additive may also be adding to potential health risks.

There are four types of caramel coloring used by manufacturers. Some of them contain 4-methylimidazole (4-MeI), a possible cancer causing chemical. But the ingredient labels on our food and beverages don’t specify which caramel color is being used so a consumer can’t tell. There is no federal limit for levels of 4-MeI in foods and beverages currently, but California’s Proposition 65 requires manufacturers to label a product sold in the state with a cancer risk warning if it exposes consumers, on average, to more than 29 micrograms of 4-MeI per day.

Consumer Reports tested 12 brands of sodas and soft drinks from five manufacturers for levels of 4-MeI. The samples were purchased over the course of seven months in California and in the New York metro area. While levels varied across brands, the tests found that some 12 ounce cans or bottles contained more than 29 micrograms of 4-MeI. The sample size was not big enough to draw conclusions about brands or to recommend one brand over another, but Consumer Reports’ experts believe that the presence, particularly at higher levels, found in some brands sampled is worrisome—and poses an unnecessary risk. Ideally there would be no 4-MeI in colors used in food.

The organization has also asked the California Attorney General to investigate whether the amounts of 4-MeI it found in certain of the sodas purchased could expose consumers to average daily levels sufficient to warrant cancer risk labeling so that consumers could make informed choices about their intake. See the full results of Consumer Reports’ testing.

In response to our testing, the Food and Drug Administration has said that it is taking a closer look at the caramel coloring in a variety of foods, including soda. We’re pleased that this issue is on the FDA’s radar. While the FDA said it currently doesn’t believe that 4-MeI from caramel color at levels currently in food pose a risk, it is also reviewing new safety data on 4-MeI to determine what, if any, regulatory action needs to be taken. Consumers Union, the policy and advocacy arm of Consumer Reports, is asking the agency to set a federal standard to limit 4-MeI in food and beverages so as not to exceed the negligible cancer risk level based on exposure from a serving of a given product. Consumers Union is also asking the FDA to require manufacturers to disclose which type of caramel coloring is in a product, so consumers can make a more informed decision.

In addition, we are concerned that manufacturers aren’t being straight with consumers when labeling products containing 4-MeI as “natural." We believe the use of the “natural” label on foods and beverages containing any artificial ingredient is misleading, including the artificial ingredient caramel color. That’s why Consumers Union is also asking the FDA to ban the use of the “natural” label on products that contain caramel color and any artificial color, and require ingredient labels to include the word “artificial.”

Consumers Union has also reached out to the Federal Trade Commission to share additional concerns we have about false representation and deceptive marketing practices by caramel color manufacturers. Some industry players present caramel color as Generally Recognized as Safe by the Food and Drug Administration, when in fact it’s not. Federal law requires food color additives—such as caramel coloring—to be regulated in a different way (although as noted there are no current limits for 4-MeI in food). Therefore the FDA doesn’t consider them or any colors they regulate to be Generally Recognized as Safe.

Regulations and rules regarding caramel coloring can already be confusing for consumers, which is why we think that manufacturers shouldn’t make it harder for consumers to find out what’s in their food. We’re committed to working with the FDA and FTC to limit consumer exposure to caramel coloring and cut through industry jargon on labels.

And we want your help. Visit to learn more about 4-MeI and send a message to the FDA to reduce the 4-Mel in soft drinks and improve labeling.

This feature is part of a regular series by Consumers Union, the policy and advocacy arm of Consumer Reports. The nonprofit organization advocates for product safety, financial reform, safer food, health reform, and other consumer issues in Washington, D.C., the states, and in the marketplace.

Read other installments of our Policy & Action feature.

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